Ongoing Trials Poster Session 1 – Wednesday, December 8, 2021: 5:00 pm – 6:30 pm CT
   
  Adjuvant radio- and chemotherapy timing - concurrent or sequential?
OT1-01-01 A randomized, pragmatic trial investigating the timing of radiotherapy and endocrine in patients with early stage breast cancer (REaCT-RETT trial)
Mc Gee SF, Clemons M, Liu M, Jemaan Alzahrani M, Ng T, Awan A, Sehdev S, Hilton J, Caudrelier JM, Savard MF, Fallowfield L, Kumar V, Freedman O, Fergusson D, Pond G, Hutton B, Bourque JM. The Ottawa Hospital, Ottawa, ON, Canada; The Ottawa Hospital Research Institute, Ottawa, ON, Canada; University of Sussex, Sussex, United Kingdom; Markham Stouffville Hospital, Markham, ON, Canada; Lakeridge Health, Oshawa, ON, Canada; McMaster University, Hamilton, ON, Canada.
   
  Antibody-drug Conjugates
OT1-02-01 Phase III postneoadjuvant study evaluating sacituzumab govitecan (SG), an antibody drug conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA
Marmé F, Schmidt M, Furlanetto J, Denkert C, Goncalves A, Stickeler E, Reinisch M, Antolín S, Reimer T, Janni W, Aftimos P, Untch M, Michel L, Balic M, Sinn B, Möbus V, Morris P, Schöllhorn L, Schmatloch S, Rey J, Loibl S. University Clinic Mannheim, Mannheim, Germany; Medical University Mainz, Mainz, Germany; German Breast Group, Neu-Isenburg, Germany; Institute of Pathology Philipps-University, Marburg, Germany; Institute Paoli Calmete, Marseille, France; University Clinic RWTH, Aachen, Germany; Kliniken Essen-Mitte, Essen, Germany; University Hospital Complex A Coruña, Hospital Teresa Herrera (CHUAC), Medical Oncology Service, Coruña, Spain; Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany; University Clinic Ulm, Ulm, Germany; Clinical Trials Conduct Unit, Institut Jules Bordet - Université Libre de Bruxelles, Brussels, Belgium; Helios Kliniken Berlin-Buch, Berlin, Germany; University Clinic Heidelberg, Heidelberg, Germany; Medical University of Graz, Clinical Department of Oncology, Graz, Austria; Institute of Pathology, Charité, Berlin, Germany; Internal Medicine II, Dept. of Hematology & Oncology University of Frankfurt, Frankfurt, Germany; Cancer Trials Ireland, Dublin, Ireland; Elisabeth Krankenhaus Kassel, Kassel, Germany.
OT1-02-02 A global, phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens
Lu J, Kalinsky KM, Tripathy D, Sledge GW, Gradishar W, O’Regan R, O’Shaughnessy J, Modi S, Drago J, Park H, McCartney A, Frentzas S, Shannon C, Cuff K, Eek R, Miguel M, Curigliano G, Jerusalem G, Huang C-S, Press M, Li M, Xu D, Song C, Huhn R, Yan J, Hurvitz S. University of Southern California, Los Angeles, CA; Emory University, Atlanta, GA; MD Anderson, Houston, TX; Stanford University, Stanford, CA; Northwestern University, Chicago, IL; University of Rochester, Rochester, NY; Baylor-Sammons Cancer Center., Dallas, TX; Memorial Sloan Kettering Center, New York City, NY; Washington University School of Medicine, St. Louis, MO; Monash Health, Clayton, Australia; Mater Health Services, South Brisbane, Australia; Princess Alexandra Hospital, Woolloongabba, Australia; Border Medical Oncology, Albury, Australia; Hospital General Universitario Gregorio Marañón, Madrid, Spain; European Institute of Oncology, IRCCS and University of Milano, Milan, Italy; University of Liège, Liege, Belgium; National Taiwan University College of Medicine, Taiwan, Taiwan; Ambrx, Princeton, NJ.
OT1-02-03 Trastuzumab deruxtecan (T-DXd; DS-8201) vs trastuzumab emtansine (T-DM1) in high-risk patients with HER2-positive, residual invasive early breast cancer after neoadjuvant therapy: A randomized, phase 3 trial (DESTINY-Breast05)
Geyer, Jr CE, Untch M, Prat A, Rastogi P, Niikura N, Mathias E, McLean LA, Wang Y, Loibl S. NSABP Foundation and Houston Methodist Cancer Center, Houston, TX; AGO B and Helios Hospital Berlin-Buch, Berlin, Germany; Hospital Clínic Barcelona, Barcelona, Spain; NSABP Foundation and University of Pittsburgh, Pittsburgh, PA; Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan; Daiichi Sankyo, Inc., Basking Ridge, NJ; German Breast Group, Neu-Isenburg, Germany.
OT1-02-04 Enfortumab vedotin 202: Phase 2 study of enfortumab vedotin for previously treated advanced solid tumors, including breast cancer
Ono M, Bruce JY, Feinstein T, Muro K, Derleth C, Gorla S, Wu C, Novik Y. The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; University of Wisconsin Carbone Cancer Center, Madison, WI; Piedmont Cancer Institute, Atlanta, GA; Aichi Cancer Center Hospital, Nagoya, Japan; Seagen Inc., Bothell, WA; Astellas Pharma, Inc., Northbrook, IL; NYU Langone Medical Center, New York City, NY.
   
  Autologous anti-HER2 macrophages
OT1-03-01 A phase 1, first in human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in subjects with HER2 overexpressing solid tumors
Abdou YG, Barton D, Ronczka A, Cushing D, Klichinsky M, Reiss Binder K. University of North Carolina, Chapel Hill, NC; Carisma Therapeutics, Philadelphia, PA; University of Pennsylvania, Philadelphia, PA.
   
  Axillary Treatment
OT1-04-01 ATNEC: A multi-centre, randomised trial investigating whether axillary treatment can be avoided in T1-3N1M0 breast cancer patients with no residual cancer in the lymph glands after neoadjuvant chemotherapy (clinicaltrials.gov: nct04109079)
Goyal A, Cramp S, Marshall A, Wheatley D, Hammonds N, Puri S, Homer T, Vale L, Butt R, Mir R, Rose J, Edwards HT, Ahmed S, Shaaban A, Elsberger B, Bruce J, Gasson S, Speirs V, Shaw J, Higgins H, Dunn J. Royal Derby Hospital, Derby, United Kingdom; University of Warwick, Coventry, United Kingdom; Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom; Newcastle University, Newcastle upon Tyne, United Kingdom; Mount Vernon Cancer Centre, Northwood, United Kingdom; NCRI Breast Clinical Studies Group, London, United Kingdom; Independent Cancer Patients' Voice, London, United Kingdom; University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom; Aberdeen Royal Infirmary, Aberdeen, United Kingdom; University of Aberdeen, Aberdeen, United Kingdom; University of Leicester, Leicester, United Kingdom.
OT1-04-02 The NAUTILUS trial (No Axillary sUrgical Treatment In clinically Lymph node negative patients after UltraSonography): A prospective multicenter randomized phase III trial (NCT04303715)
Lee H-B, Jung JG, Chang JM, Chang JH, Moon WK, Shin KH, Chung IY, Nam SJ, Kim E-K, Lee S, Park S, Lim WS, Jung Y, Han W. Seoul National University College of Medicine, Seoul, Republic of Korea; Asan Medical Center, Seoul, Republic of Korea; Samsung Medical Center, Seoul, Republic of Korea; Seoul National University Bundang Hospital, Seongnam, Republic of Korea; National Cancer Center, Goyang, Republic of Korea; Yonsei University College of Medicine, Seoul, Republic of Korea; Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea; Ajou University Hospital, Suwon, Republic of Korea.
OT1-04-03 Sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A multicentre prospective randomized controlled trial (VENUS trial)
Mendes Duarte G, Myiamoto Araújo DC, Menezes Jales R, Yoriko Shinzato J, Cardoso, Filho C, Zocchio Torresan R, Palermo Brenelli F, de PaulaLeite Kraft MB, Barros Esteves SC, Otávio Zanatta Sarian L, MecedoSousa Rahal R, de Freitas, Jr R, Carvalho Pessoa E, Ênio Murta Lucena C, PiresSouto Damin A, Villanova Biazus J, Milani Budel V, de Oliveira, Jr I, Aloisio da Costa Vieira R, Narciso Gomes JC. Universidade Estadual de Campinas - UNICAMP, Campinas, Brazil; Universidade Federal de Goias, Goiania, Brazil; Universidade Estadual Paulista - UNESP, Botucatu, Brazil; Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Universidade Federal do Paraná, Curitiba, Brazil; Hospital de Amor- Fundação Pio XII, Barretos, Brazil; Hospital de Câncer de Muriaé, Muriaé, Brazil; Pontifícia Universidade Católica de Campinas, Campinas, Brazil.
OT1-04-04 AXSANA - EUBREAST 3 (axillary surgery after neoadjuvant treatment): An international prospective multicenter cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655)
Kühn T, Hartmann S, Stickeler E, de Boniface J, Gentilini O, Fröhlich S, Ruf F, Thill M, Hauptmann M, Karadeniz Cakmak G, Rubio I, Gasparri ML, Kontos M, Bonci E-A, Niinikoski L, Di Micco R, Murawa D, Pinto D, Peintinger F, Solbach C, Appelgren M, Blohmer J-U, Weigel M, Kaltenecker G, Schrauder M, Simons J, Smidt M, Schlichting E, Dostalek L, Sergeevich Emelyanov A, Thiemann E, Gunay S, Loibl S, Banys-Paluchowski M. Klinikum Esslingen GmbH, Esslingen, Germany; University Hospital Rostock, Department of Gynecology and Obstetrics, Rostock, Germany; University Hospital Aachen, Department of Gynecology and Obstetrics, Aachen, Germany; Karolinska Institutet, Department of Moledular Medicine and Surgery, Stockholm, Sweden; San Raffaele University and Research Hospital, Breast Surgery Unit, Milan, Italy; University Hospital of Schleswig Holstein, Department of Obstetrics and Gynecology, Lübeck, Germany; AGAPLESION Markus Krankenhaus, Department of Gynecology and Gynecological Oncology, Frankfurt am Main, Germany; Brandenburg Medical School Theodor Fontane, Neuruppin, Germany; Zonguldak BEUN The School of Medicine, General Surgery Department, Breast and Endocrine Unit, Kozlu/zonguldak, Turkey; Clínica Universidad de Navarra, Breast Surgical Unit, Madrid, Spain; Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Department of Gynecology and Obstetrics, Lugano, Switzerland; Laiko Hospital, National and Kapodistrian University of Athens, 1st Department of Surgery, Athens, Greece; ”Prof. Dr. Ion Chiricuță” Institute of Oncology, Department of Surgical Oncology, Cluj-Napoca, Romania; Helsinki University Hospital, University of Helsinki, Breast Surgery Unit, Comprehensive Cancer Center, Helsinki, Finland; University of Zielona Góra, Department of General Surgery and Surgical Oncology, Collegium Medicum, Zielona Góra, Poland; Champalimaud Clinical Center, Champalimaud Foundation, Breast Unit, Lisabon, Portugal; Medical University of Graz, Institute of Pathology, Graz, Austria; University of Frankfurt, Department of Gynecology and Obstetrics, Frankfurk am Main, Germany; Karolonska Institutet, Dept. of Molecular Medicine and Surgery, Stockholm, Sweden; Charité Campus Mitte, Department of Gynecology and Breast Cancer Center, Esslingen, Germany; Leopoldina Krankenhaus Schweinfurt, Schweinfurt, Germany; Städtisches Klinikum Karlsruhe, Karlsruhe, Germany; Klinikum Aschaffenburg-Alzeneu, Aschaffenburg, Germany; Maastricht University, GROW – School for Oncology and Developmental Biology, Maastricht, Netherlands; Oslo University Hospital, Department of Oncology, Oslo, Norway; Charles University, General University Hospital, First Faculty of Medicine, Gynecologic Oncology Center, Department of Obstetrics and Gynecology, Prague, Czech Republic; N.N. Petrov NMRC of Oncology, Petersburg, Russian Federation; Niels-Stensen-Kliniken, Brustzentrum Osnabrück, Osnabrück/Georgsmarienhütte, Germany; Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital, Ministry of Health Istanbul Provinicial, Istanbul, Turkey; GBG – German Breast Group, Neu-Isenburg, Germany; University Hospital of Schleswig Holstein, Campus Lübeck, Department of Obstetrics and Gynecology, Lübeck, Germany.
   
  Biomarkers of response
OT1-05-01 Glycoprotein 88 (GP-88) serum levels as a marker of response to therapy in patients with metastatic breast cancer
Tkaczuk KHR, Rosenbatt P, Sulkowski S, Tait N, Yue B, Serrero G. University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, MD; University of Maryland School of Medicine, Baltimore, MD; A & G Pharmaceutical Inc, Columbia, MD.
   
  Bone metastases
OT1-06-01 A randomised trial comparing continuation or de-escalation of bone modifying agents (BMA) in patients treated for over 2 years for bone metastases from either breast or castration-resistant prostate cancer (REaCT-HOLD BMA)
Ng TL, Pond GR, Sienkiewicz M, Thavorn K, Clemons M. University of Ottawa, Ottawa, ON, Canada; McMaster University, Hamilton, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada.
OT1-06-02 SMALL - Open surgery versus minimally invasive vacuum-assisted excision for small screen detected breast cancer: A phase 3 randomised trial
McIntosh SA, Coles CE, Conefrey C, Dodwell D, Elder K, Foster J, Gaunt C, Kirkham A, Lyburn I, Morgan J, Paramasivan S, Pinder S, Pirrie S, Potter S, Roberts T, Sharma N, Stobart H, Southgate E, Taylor-Phillips S, Wallis M, Rea D. Queen's University Belfast, Belfast, United Kingdom; University of Cambridge, Cambridge, United Kingdom; University of Bristol, Bristol, United Kingdom; University of Oxford, Oxford, United Kingdom; NHS Lothian, Edinburgh, United Kingdom; University of Birmingham, Birmingham, United Kingdom; Cheltenham General Hospital, Cheltenham, United Kingdom; University of Sheffield, Sheffield, United Kingdom; King's College, London, United Kingdom; St James's University Hospital, Leeds, United Kingdom; Independent Cancer Patients' Voice, Cambridge, United Kingdom; University of Warwick, Warwick, United Kingdom; Addenbrooke's Hospital, Cambridge, United Kingdom .
   
  Brain Metastases
OT1-07-01 MRI screening versus symptom-directed surveillance for brain metastases among patients with triple negative or HER2+ metastatic breast cancer: A pilot study (nct03881605)
Jerzak KJ, Sahgal A, Pond G, Brastianos PK, Freedman O, Stanisz G, Warner E. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada; McMaster University, Hamilton, ON, Canada; Harvard University, Boston, MA; Lakeridge Health, Oshawa, ON, Canada; Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.
OT1-07-02 Withdrawn
   
  Chemoendocrine therapy - concurrent vs. sequential
OT1-08-01 Concurrent versus sequential chemo-endocrine therapy in er positive and her2 negative non-metastatic breast cancer- an open-label, phase III, randomized controlled trial
Joshi S, Murali-Nanavati S, Vanmali V, Hawaldar R, Gafur Shaikh M, Sadique Ansari M, Rath S, Ghosh J, Gulia S, Bajpayi J, Nair N, Parmar V, Thakkar P, Chitkara G, Shet T, Desai S, Sahay A, Gupta S, Badwe R. Tata Memorial Hospital, Mumbai, India.
   
  DCIS
OT1-09-01 A randomized study comparing surgical excision versus NeOadjuvant Radiotherapy followed by delayed surgical excision of Ductal carcinoma In Situ (NORDIS)
Wapnir I, Marquez C, Stone K, Allison K, DeMartini W, Salem C, Tsai J, West R, McMillan A, Telli M, Horst K. Stanford University School of Medicine, Stanford, CA. .
OT1-09-02 The PREDICT Registry: A prospective registry to evaluate the effect of a predictive assay on treatment decisions in patients with DCIS following breast conserving therapy
Shivers SC, Whitworth PW, Patel R, Bremer T, Cox CE. PreludeDx, Laguna Hills, CA; Nashville Breast Center, Nashville, TN; Good Samaritan Cancer Center, Los Gatos, CA; University of South Florida, Tampa, FL.
   
  Endocrine Therapy
OT1-10-01 The Breast Cancer Index registry study: A prospective multi-center observational study to evaluate patient outcome, clinical impact, and medication adherence in HR+ breast cancer patients considering treatment with extended endocrine therapy
O'Shaughnessy JA, Fox JR, Encarnación CA, O'Neal B, Treuner K, Sanft T, Jankowitz RC, Pegram MD, Schnabel CA, Diab SG. Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX; Rocky Mountain Cancer Center, US Oncology, Boulder, CO; Texas Oncology, US Oncology, Waco, TX; Biotheranostics, Inc., San Diego, CA; Yale School of Medicine, New Haven, CT; University of Pennsylvania, Pittsburgh, PA; Stanford Comprehensive Cancer Institute, Palo Alto, CA; Rocky Mountain Cancer Center, US Oncology, Aurora, CO.
OT1-10-02 I-SPY2 endocrine optimization protocol (EOP): A pilot neoadjuvant endocrine therapy study with amcenestrant as monotherapy or in combination with abemacicilib or letrozole in molecularly selected HR+/HER2- clinical stage 2/3 breast cancer
Chien AJ, Kalinsky KM, Molina-Vega J, Mukhtar R, Giridhar K, Olopade OI, Basu A, Asare SM, Henderson P, Hirst G, Lu R, Jones E, Hylton N, Brown-Swigart L, van 't Veer LJ, Yee D, Mayer I, Esserman LJ. University of California, San Francisco, San Francisco, CA; Emory Winship Cancer Institute, Atlanta, GA; Mayo Clinic Breast Cancer Center, Rochester, MN; University of Chicago Medical Center, Chicago, IL; Quantum Leap Healthcare Collaborative, San Francisco, CA; University of Minnesota, Minneapolis, MN; Vanderbilt University, Nashville, TN.
   
  Endocrine Therapy - dose timing
OT1-11-01 The PREDICT registry Australia: A prospective registry study to evaluate the clinical utility of the DCISionRT test on treatment decisions in patients with DCIS following breast conserving surgery
Zissiadis Y, Mann GB, Shivers SC, Bremer T. GenesisCare, Perth, Australia; Royal Women's Hospital, Parkville, Australia; PreludeDx, Laguna Hills, CA.
OT1-11-02 A pragmatic, randomised, multicentre trial evaluating the dose timing (morning vs evening) of endocrine therapy and its effects on tolerability and compliance (REaCT-CHRONO Study)
Savard M-F, Ibrahim M, Pond G, Saunders D, Vandermeer L, Beltran-Bless A-A, Fallowfield L, Clemons M. University of Ottawa, Ottawa, ON, Canada; Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada; McMaster University, Hamilton, ON, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada; SHORE-C, Brighton & Sussex Medical School, Brighton, United Kingdom .
   
  HER2
OT1-12-01 Solti-1804 HER2-PREDICT: Translational study of tumor samples from breast cancer patients treated with trastuzumab deruxtecan in the metastatic setting
Prat A, Saura C, Cruz J, Nogales Fernández E, Bofill5 JS, Gavilá J, Bermejo-Perez MJ, Quiroga V, Morales S, Servitja S, de Toro R, Zamora P, Galván P, Chic N, Martínez D, Brasó-Maristany F, Canes J, Paré L, Ferrero-Cafiero JM, Pascual T, Pernas S. SOLTI / Medical Oncology Department, Hospital Clínic de Barcelona / Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; SOLTI Breast Cancer Research Group / Medical Oncology Department, Vall d'Hebron University Hospital / Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Medical Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; Medical Oncology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain; Medical Oncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain; SOLTI / Medical Oncology Department, IVO Instituto Valenciano de Oncología, Valencia, Spain; UGCI Oncol. Hosp Univer Regional y Virgen Victoria. IBIMA, Málaga, Spain; Medical Oncology Department, ICO Badalona, Institut Català d’Oncologia, Barcelona, Spain; Medical Oncology Department, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain; Medical Oncology Department, Hospital del Mar, Barcelona, Spain; Medical Oncology Department, Hospital Universitario de Jerez, Jerez de la Frontera, Spain; Medical Oncology Department, Hospital La Paz, Madrid, Spain; Translational Genomics and Targeted Therapies in Solid Tumors Lab, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Medical Oncology Department, Hospital Clínic de Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; Medical Oncology Department, Hospital Clínic de Barcelona / Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain; SOLTI / Medical Oncology Department, Institut Catala d’ Oncologia-L’Hospitalet, L’Hospitalet de Llobregat, Spain.
OT1-12-02 Trial in progress: Phase 2, open-label study to evaluate the safety and efficacy of praluzatamab ravtansine in metastatic HER2 non-amplified breast cancer as monotherapy and combination with pacmilimab
Miller K, Emens LA, Tolaney SM, Hurvitz SA, Hamilton E, Paton V, Hannah A, Boni V. Indiana University Simon Cancer Center, Indianapolis, IN; University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; University of California, Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA; Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; CytomX Therapeutics, Inc., South San Francisco, CA; START Madrid CIOCC, Comprehensive Cancer Center Clara Campal, HM Universitary Hospital Sanchinarro, Madrid, Spain.
OT1-12-03 Phase II study of pyrotinib plus nanoparticle albumin-bound (nab)-paclitaxel as adjuvant therapy for lymph node-negative (N0) or micrometastatic (N1mi), HER2-positive early breast cancer (PHAEDRA)
Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Department of Breast Surgery, Peking Union Medical College Hospital, Beijing, China.
OT1-12-04 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP compared with ddAC-THP in patients with high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11)
Harbeck N, Boileau J-F, Modi S, Kelly CM, Ohno S, Wu J, Brekenridge M, Herbolsheimer P, Yu T, Pusztai L. Breast Center, Department of Gynecology and Obstetrics and CCC Munich, LMU Hospital, Munich, Germany; Jewish General Hospital Segal Cancer Centre, McGill University, Montréal, QC, Canada; Memorial Sloan Kettering Cancer Center/Weill Cornell Medical College, New York, NY; Mater Misericordiae University Hospital, Dublin, Ireland; Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Fudan University Shanghai Cancer Center, Shanghai, China; AstraZeneca Pharmaceuticals, Gaithersburg, MD; Yale Cancer Center, Yale School of Medicine, New Haven, CT.
OT1-12-05 Phase II neoadjuvant trial evaluating trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early stage breast cancer
Hurvitz S, Bardia A, Tetef ML, McAndrew NP, Applebaum S, Master AK, DiNome ML, Lee MK, Kirimis E, Kim DD, Wang LS, Greene K, Phan V, Abdulla N, Chan D, Spring LM, Kivork C, Chauv J. University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School, Boston, Boston, MA; PIH Health, Whittier, CA; Cancer Blood and Specialty Clinic, Los Alamitos, CA; Torrance Memorial Physician Network (TMPN)/Cancer Care, Torrance, CA.
OT1-12-06 Neoadjuvant pyrotinib versus pertuzumab in combination with trastuzumab and nab-Paclitaxel for patients with HER2-positive early or locally advanced breast cancer (Pyramid): A randomized, multicenter, open-label, phase 2 trial
Zhang J, Liu Q, Jiang H, Zhang J, Ou J, Chen D, Tian F, Li Y, Cheng X, Ouyang Z. Tianjin Medical University Cancer Institute and Hospital, Tianiin, China; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Beijing Chaoyang Hospital, Beijing, China; The Second Affiliated Hospital of Harbin Medical University, Harbin, China; The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China; Yunnan Cancer Hospital, Kunming, China; Shanxi Cancer Hospital, Taiyuan, China; Shandong Cancer Hospital, Jinan, China; Affiliated Hospital of Zunyi Medical University, Zunyi, China; The First Affiliated Hospital of Xiamen University, Xiamen, China.
OT1-12-07 A phase 2 study of chemotherapy de-escalation using a pathological response-guided strategy in patients with HER2-positive, low-risk early breast cancer: PHERGain-2
Pérez-García JM, Guerrero-Zotano Á, Medioni J, Schneeweiss A, Colleoni M, Sampayo-Cordero M, Malfettone A, Cortés J, Llombart-Cussac A. International Breast Cancer Center (IBCC), Quironsalud Group; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Instituto Valenciano de Oncología, Valencia; Medica Scientia Innovation Research (MedSIR), Ridgewood, New Jersey, US, Barcelona, Spain; Hôpital Européen Georges Pompidou AP-HP, Paris, France; National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany; European Institute of Oncology, IRCCS, Milan, Italy; Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; International Breast Cancer Center (IBCC), Quironsalud Group; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain; Hospital Arnau de Vilanova; FISABIO; Universidad Católica de Valencia, Valencia; Medica Scientia Innovation Research (MEDSIR), Ridgewood, New Jersey, Barcelona, Spain.
OT1-12-08 Randomized study comparing electronic patient reported outcomes (ePROs) monitoring with routine follow up during trastuzumab deruxtecan treatment in patients with inoperable or metastatic breast cancer (PRO-DUCE study)
Sangai T, Kikawa Y, Hosoda M, Hamanaka Y, Tanabe Y, Yoshida T, Tane K, Takabatake D, Taira T, Araki K, Iwamoto T, Takada M, Narui K, Yamaguchi T, Yamada A, Miura T, Uemura Y, Aihara T, Mukai H, Taira N. Kitasato University Hospital, Sagamihara, Japan; Kansai Medical University Hospital, Osaka, Japan; Sunagawa City Medical Center, Hokkaido, Japan; Tohoku University, Sendai, Japan; Toranomon Hospital, Tokyo, Japan; Saiseikai Yokohamashi Nanbu Hospital, Kanagawa, Japan; Hyogo Cancer Center, Hyogo, Japan; Kochi Health Science Center, Kochi, Japan; Sagara Hospital, Kagoshima, Japan; Gunma Prefectural Cancer Center, Gunma, Japan; Okayama University Hospital, Okayama, Japan; Chiba University Graduate School of Medicine, Chiba, Japan; Yokohama City University Medical Center, Kanagawa, Japan; Yokohama City University Hospital, Kanagawa, Japan; Daiichi Sankyo Co., Ltd., Tokyo, Japan; National Center for Global Health and Medicine, Tokyo, Japan; Aihara Hospital, Osaka, Japan; National Cancer Center Hospital East, Chiba, Japan.
OT1-12-09 Time and motion study of a subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of patients with HER2-positive early breast cancer (PHaTiMa)
Gavilá Gregori J, López Miranda E, Escrivá-de-Romaní S, Jiménez Rodríguez B, Antolín Novoa S, Fernández Morales L, Galve Calvo E, González Cortijo L, Perelló Martorell A, Lagunar Ruiz J, González Santiago S. Instituto Valenciano de Oncología, Valencia, Spain; Hospital Universitario Ramón y Cajal, Madrid, Spain; Hospital Vall d'Hebron and Vall d'Hebron Instituto de Oncología (VHIO), Barcelona, Spain; Hospital Universitario Virgen de la Victoria, Málaga, Spain; Hospital Universitario de A Coruña, A Coruña, Spain; Parc Taulí Hospital Universitari, Sabadell, Spain; Hospital Universitario Basurto, Bilbao, Spain; Hospital Universitario Quirónsalud Madrid, Madrid, Spain; Hospital Universitari Son Espases, Palma, Spain; Roche Farma, Madrid, Spain; Hospital San Pedro de Alcántara, Cáceres, Spain.
   
  HER2 - brain metastases
OT1-13-01 HER2CLIMB-04: phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (trial in progress)
Hamilton E, Carey L, Ramos J, Chen Y, Krop I. Sarah Cannon Research Institute/Tennessee Oncology PLLC, Nashville, TN; UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Seagen Inc., Bothell, WA; Dana-Farber Cancer Institute, Boston, MA.
   
  HER2 mab
OT1-14-01 Zanidatamab in combination with ALX148 in advanced human epidermal growth factor receptor 2 (HER2)‑expressing cancers, including breast cancer: A phase 1b/2, multicenter, open‑label, dose‑finding and cohort‑expansion study (ZWI‑ZW25‑204)
Hurvitz SA, Chaves J, Brufsky A, Montero AJ, Fang B, Yeung K, Patel MR, Parajuli R, Omidpanah A, Gartner E, Fong A, Randolph S, Meric-Bernstam F. University of California, Los Angeles; Jonsson Comprehensive Cancer Center, Los Angeles, CA; Northwest Medical Specialties, Tacoma, WA; University of Pittsburgh School of Medicine, Pittsburgh, PA; UH Cleveland Medical Center/Seidman Cancer Center Case Western Reserve University, Cleveland, OH; Astera Cancer Care, East Brunswick, NJ; University of California San Diego Health Moores Cancer Center, La Jolla, CA; Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL; University of California, Irvine, Orange, CA; Zymeworks Inc., Vancouver, BC, Canada; ALX Oncology Inc, Burlingame, CA; The University of Texas MD Anderson Cancer Center, Houston, TX.
OT1-14-02 Phase 3 study of trastuzumab deruxtecan (T-DXd) with or without pertuzumab vs a taxane, trastuzumab and pertuzumab in first-line (1L), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (mBC): DESTINY-Breast09
Tolaney SM, Barroso-Sousa R, Jiang Z, Park YH, Rimawi M, Saura C, Schneeweiss A, Toi M, Yu T, Shetty J, Herbolsheimer P, Loibl S. Dana-Farber Cancer Institute, Boston, MA; Oncology Center, Hospital Sírio-Libanês, Brasília, Brazil; The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; Baylor College of Medicine, Houston, TX; Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; National Center for Tumor Diseases, Heidelberg, Germany; Kyoto University, Kyoto, Japan; AstraZeneca Pharmaceuticals, Gaithersburg, MD; GBG Forschungs GmbH, Neu-Isenburg, Germany; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany.
   
  HER2 mutants
OT1-15-01 SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations: HER2-mutated breast cancer cohort (ongoing clinical trial)
Okines A, Pohlmann PR, Ramos J, Walker L, Hamilton E. The Royal Marsden Hospital, London, United Kingdom; MD Anderson Cancer Center, Houston, TX; Seagen Inc., Bothell, WA; Sarah Cannon Research Institute/Tennessee Oncology PLLC, Nashville, TN.
   
  HER2 vaccines
OT1-16-01 A multicenter phase II study of vaccines to prevent recurrence in patients with HER-2 positive breast cancer
Han HS, Disis M, Wesolowski R, Fisher C, Gandhi S, Chan N, Gwin W, Gogineni K, Mick R, Sierra Rodriguez C, Hogue D, Liu H, Costa R, Czerniecki B. Moffitt Cancer Center and Research Institute, Tampa, FL; University of Washington, Seattle, WA; Ohio State University, Columbus, OH; Indiana University School of Medicine, Indianapolis, IN; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Rutgers Cancer Institute of New Jersey, New Brunswick, NY; Emory Winship Cancer Institute, Atlanta, GA; University of Pennsylvania School of Medicine, Philadelphia, PA.
   
  Immune checkpoint inhibitors
OT1-17-01 Solti-1716. Targeting with pembrolizumab + paclitaxel non-luminal by PAM50 hormone receptor-positive/HER2-negative advanced/metastatic breast cancer patients who have progressed on or after CDK4/6 inhibitor treatment (TATEN trial)
Ciruelos E, Muñoz M, Oliveira M, Chic N, Hernando C, Viruzuela JA, Vázquez S, Blanch S, Paré L, Salvador F, Villagrasa P, Pascual T, Prat A. SOLTI Breast Cancer Research Group/Hospital 12 de Octubre, Barcelona/Madrid, Spain; SOLTI Breast Cancer Research Group/Hospital Clinic de Barcelona/August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Vall d'Hebron University Hospital/SOLTI Breast Cancer Research Group/Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Spain; Hospital Clínico Universitario de Valencia, Valencia, Spain; Hospital Quirón Sagrado Corazón, Sevilla, Spain; Hospital Duran i Reynals-Institut Català d’Oncologia, Hospitalet de Llobregat, Barcelona, Spain; IVO Instituto Valenciano de Oncología, Valencia, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Clinic de Barcelona/SOLTI Breast Cancer Research Group/August Pi i Sunyer Biomedical Research Institute (IDIBAPS)/Medicine Department, University of Barcelona, Barcelona, Spain.
OT1-17-02 A phase II study of pembrolizumab plus fulvestrant in hormone receptor positive, HER-2 negative advanced/metastatic breast cancer patients
Chan N, Moore D, Tandra P, Rana J, Omene C, George M, Krishnamurthy J, Desai S, Patel N, Wang Y, Bicomong M, Tan X-w, Hirshfield K, Ganesan S, Toppmeyer D. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; University of Nebraska, Omaha, NE; Michigan State University, Lansing, MI; Robert Wood Johnson Medical School, New Brunswick, NJ.
   
  Immunotherapy
OT1-18-01 A randomized controlled phase III study of bevacizumab and paclitaxel in combination with atezolizumab as a treatment for patients with locally advanced or metastatic hormone receptor-positive HER2 negative breast cancer: JCOG1919E/AMBITION study
Hara F, Ono M, Kitano S, Saji S, Shimomura A, Yamanaka T, Kadoya T, Ito M, Bando H, Yasojima H, Sasaki K, Kataoka T, Shien T, Yonemori K, Iwata H. Department of Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan; Department of Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan; Department of Cancer Immunotherapy, Cancer Institute Hospital of JFCR, Tokyo, Japan; Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan; Department of Breast and Medical Oncology National Center for Global Health and Medicine, Tokyo, Japan; Department of Breast and Endocrine Surgery Kanagawa Cancer Center, Kanagawa, Japan; Department of Surgical Oncology Research Institute for Radiation Biology and Medicine, Hiroshima, Japan; Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan; Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan; Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan; Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, Aichi, Japan.
OT1-18-02 First-line chemo-immunotherapy with durvalumab, paclitaxel and carboplatin with or without anti-CD73 antibody oleclumab in advanced or metastatic triple-negative breast cancer: Preliminary results of the randomized phase II SYNERGY trial
Debien V, Maurer C, Aftimos P, Clatot F, Loirat D, Punie K, Ghiringhelli F, Gonçalves A, Taylor D, Van den Mooter T, Ferrero J-M, Bonnefoi H, Canon J-L, Duhoux F, Poncin R, Bazan F, Isambert N, Barthelemy P, Brandão M, Kristanto P, Ignatiadis M, Piccart M, Buisseret L. Institut Jules Bordet, Université Libre de Bruxelles (U.L.B.), Brussels, Belgium; Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany; Centre Henri Becquerel, Rouen, France; Institut Curie, Paris, France; Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium; Centre Georges François Leclerc, Dijon, France; Institut Paoli-Calmettes, Aix Marseille Université, Centre de Recherche en Cancérologie de Marseille (CRCM), Marseille, France; Université Catholique de Louvain, CHU UCL Namur, Sainte Elisabeth, Namur, Belgium; Gasthuiszusters Antwerpen, Antwerpen,, Belgium; Centre Antoine Lacassagne, University Côte d'Azur, Nice, France; Institut Bergonié, Université de Bordeaux, Bordeaux, France; Grand Hôpital de Charleroi (Notre Dame), Charleroi, Belgium; Cliniques Universitaires Saint-Luc, Brussels, Belgium; Clinique Saint-Pierre, Ottignies, Belgium; CHU de Besançon, Besançon, France; CHU de Poitiers, Poitiers, France; Institut de Cancérologie de Strasbourg (ICANS), Strasbourg, France.
OT1-18-03 The neoIRX trial:locoregional cytokine therapy to promote immunologic priming and enhanced response to neoadjuvant pembrolizumab plus chemotherapy in triple negative breast cancer (TNBC)
Sanchez K, Conlin A, Peddi P, Stanton S, Ruzich J, Perlewitz K, Wu Y, Moxon N, Mellinger S, Sun Z, Redmond W, Page DB. Baylor College of Medicine, Houston, TX; Providence Cancer Institute, Portland, OR; Saint John's Cancer Center, Santa Monica, CA, CA; Providence Cancer Institute Newberg Clinic, Newburg, OR.
OT1-18-04 A phase II study of dual immune checkpoint blockade (ICB) plus bicalutamide to enhance thymic T-cell production and immunotherapy response in metastatic breast cancer (MBC)
Page DB, Collins KL, Chun B, Sun Z, Redmond WL, Martel M, Wu Y, Moxon N, Mellinger SL, Urba WJ, Traina TA, Gucalp A. Earle A. Chiles Research Institute, Portland, OR; Memorial Sloan Kettering Cancer Center, New York, NY.
OT1-18-05 A multicenter, open-label, phase 2 study of Imprime PGG and pembrolizumab in patients with metastatic breast cancer who have progressed through prior hormonal therapy
Stopeck A, Gargano M, Bose N, Niles N, Chisamore M, Iglesias J. Stony Brook Cancer Center, Stony Brook, NY; HiberCell Inc., New York, NY; Merck & Co., Inc., New Jersey, NY; APEX Oncology Consulting, Inc., Oakville, ON, Canada.
OT1-18-06 KEYNOTE-B49: A phase 3, randomized, double-blind, placebo-controlled study of pembrolizumab plus chemotherapy in patients with HR+/HER2− locally recurrent inoperable or metastatic breast cancer
Schmid P, Baccan C, Guo Z, Tryfonidis K, Rugo HS. Barts Cancer Institute, Centre for Experimental Cancer Medicine, Queen Mary University of London, London, United Kingdom; Merck & Co., Inc., Kenilworth, NJ; University of California San Francisco Comprehensive Cancer Center, San Francisco, CA.
OT1-18-07 A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy
Patel SS, McWilliams DB, Fischette CT, Thompson J, Daugherty FJ, Osborne CK, Rimawi MF. Greenwich LifeSciences, Stafford, TX; Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.
OT1-18-08 Randomized phase II trial of pembrolizumab/carboplatin vs. carboplatin alone for breast cancer with chest wall recurrence: TBCRC044
Vidula N, Nanda R, Miller K, Emens L, Abramson V, Park B, Liu MC, Goga A, Rugo H. Massachusetts General Hospital, Boston, MA; University of Chicago, Chicago, IL; Indiana University, Indianapolis, IN; University of Pittsburg, Pittsburg, PA; Vanderbilt University, Nashville, TN; Mayo Clinic, Rochester, MN; University of California San Francisco, San Francisco, CA.
   
  Metastatic breast cancer data resource
OT1-19-01 The metastatic breast cancer project: Generating the clinical and genomic landscape of metastatic breast cancer through patient-partnered research
Wagle N, Painter C, Anastasio E, McGillicuddy M, Jain E, Hernandez TG, Tomson BN, Thomas B, Abravanel D, Kim D, Balch S, Damon AL, Shah S, Ramos R, Sosa D, Small I, Nguyen C, Winnicki S, Cusher T, Chastain P, Dunphy M, Gomez Tejeda Zanudo J, Tsegai N, Sterlin L, Ulysse UF, Boykin I, Alao O Golub TR. Dana-Farber Cancer Institute, Boston, MA; Broad Institute, Cambridge, MA.
   
  Multiparameter database MBC study
OT1-20-01 Feasibility of creation of a clinico-biological database: A prospective longitudinal cohort study of metastatic breast cancer patients (epicuresein)
Colombié M, Jézéquel P, Rubeaux M, Frenel J-S, Bigot F, Seegers V, Campone M. ICO, Saint Herblain, France; Keosys, Saint Herblain, France